BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VISIAN ICL (IMPLANTABLE COLLAMER LENS)

    MDR report key: 2842578 · Received November 21, 2012

    Report

    Report Number
    2023826-2012-00936
    Event Type
    Injury
    Date Received
    November 21, 2012
    Report Date
    October 22, 2012
    Manufacturer
    STAAR SURGICAL COMPANY
    Product Code
    MTA
    PMA / PMN Number
    P030016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: WORK ORDER SEARCH, MEDICAL REVIEW. RESULTS: A LENS WORK ORDER SEARCH WAS PERFORMED AND NO SIMILAR COMPLAINTS WERE FOUND WITHIN THE WORK ORDER. GLARES AND HALOS MAY BE NOTED BY PATIENTS EVEN IF THEY NEVER HAD ANY OCULAR SURGERY. THIS IS COMMONLY DUE TO ABERRATIONS OR IRREGULARITIES IN THE CORNEA. IT MAY BE NOTED MORE AT LOW LIGHT CONDITIONS WHEN THE PUPIL IS DILATED. IN ICL SURGERY, THE CENTRAL AND MID PERIPHERAL CORNEA IS NOT TOUCHED, THEREFORE PATIENTS WHO HAVE GLARES AND HALOS BEFORE THE SURGERY, WILL COMMONLY RETAIN THESE SYMPTOMS BUT LITTLE OR NO INCREASE IN SEVERITY SHOULD BE EXPERIENCED SINCE THE CENTRAL AND MID PERIPHERAL REGION REMAINS UNABLATED AND ONLY A CORNEAL INCISION WITH A MAXIMUM LENGTH OF 3.2MM AT THE TEMPORAL PERIPHERAL REGION IS MADE. GLARE AND HALOS MAY ALSO BE PERCEIVED MORE DUE TO THE INCREASED CLARITY OF VISION AFTER ICL SURGERY OR IF THE PATIENT HAS RETAINED ASTIGMATISM. ANOTHER FACTOR COULD ALSO BE THE EFFECTIVE OPTICAL CORNEAL ZONES (EOCZ) OF THE ICLS, WHICH HAVE A MAXIMUM DIAMETER OF 6.17 TO 7.30 MM DEPENDING ON THE ICL POWERS. THIS IS A DESIGN LIMITATION WHICH MAY CREATE SIMILAR SYMPTOMS OF GLARE AND HALOS DUE TO THE INTERFACE OF THE OPTICAL ZONE AND THE PATIENT'S OPTICAL FIELD OF VISION, WHICH MAY BE NOTED WHEN THE PUPIL SIZE IS GREATER THAN THE EOCZ. CONCLUSIONS: BASED ON THE COMPLAINT HISTORY, WORK ORDER SEARCH AND MEDICAL REVIEW, A SPECIFIC ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED. (B)(4).

    Additional Manufacturer Narrative · 1

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT - UNK. (B)(4). DEVICE EVALUATED BY MANUFACTURER? NO. LENS REMAINS IMPLANTED. (B)(4).

    Description of Event or Problem · 1

    THE REPORTER INDICATED THE SURGEON IMPLANTED A 12.5MM ICM125V4 IMPLANTABLE COLLAMER LENS IN THE PATIENT'S LEFT EYE (OS) ON (B)(6) 2009. THE PATIENT HAS BEEN COMPLAINING OF VERY BAD HALOS AND HAS BEEN HAVING A PROBELM DRIVING AT NIGHT DUE TO THE HALOS. THE ICL REMAINS IMPLANTED. AT THE LAST VISIT ON (B)(6) 2010 THE PATIENT'S BCVA WAS 20/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISIAN ICL (IMPLANTABLE COLLAMER LENS) INTRAOCULAR LENS MTA STAAR SURGICAL COMPANY ICM125V4 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR CARTRIDGE MODEL AND LOT NUMBER UNK| INJECTOR MODEL AND LOT NUMBER UNK